The Misoprostol-Only Regimen Evidence Study

Starting soon · Phase 4

Conditions studied: Abortion, Medical

In brief

The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. The investigators aim to evaluate this in both in-clinic and telehealth medication abortion care in the United States. The main questions it aims to answer are: 1. What proportion of pregnant people using an updated misoprostol-only medication abortion regimen have a complete abortion using just the prescribed pills? 2. Is the updated misoprostol-only medication abortion regimen no more than 5% less effective (non-inferior) than the standard combined medication abortion regimen? 3. What is the pattern of beta hCG decline following use of a misoprostol-only medication abortion through 77 days of pregnancy? Participants will: * be randomized to one of two medication regimens (misoprostol-only or the combined regimen) in a 1:1 ratio based on duration of pregnancy at enrollment. - self-report outcomes via daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days. * return to the clinical site for tests as instructed The investigators hypothesize that the proportion with complete abortions in the misoprostol-only arm will be non-inferior to the proportion with complete abortions in the combined regimen arm within a 5% margin of inferiority

Key facts

Study ID: NCT07174856
Run by: Ibis Reproductive Health
People needed: 1900
Starts: 2025-10-10
Expected to finish: 2027-03-01
Last updated by the study team: 2025-10-08

Who can join

Age: 14 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Pregnancy of < or = 77 days duration based on LMP or ultrasound
Positive pregnancy test (self-report or in-clinic)
Age: States without parental involvement laws : in-person patients ages 14 years and older; States with parental involvement or notification laws: 18 years or older
Willing and able to give informed consent
Willing to comply with study protocol
Willing to record requested information in the study surveys
English or Spanish speaking
Has a text message, email, or phone call capable device for survey completion
Understands and signs an Institutional Review Board (IRB) approved informed consent form prior to undergoing any study procedures or randomization

You may not qualify if…

concurrent participation in any other interventional trial
unwilling to comply with the study protocol and survey/visit schedule
contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
diagnosis of porphyria
known bleeding disorder or receiving anticoagulants
pregnancy with an IUD in place
diagnosis of pregnancy of unknown location (PUL), early pregnancy failure, incomplete or inevitable abortion (absent gestational sac and/or open cervical os)
possibility of ectopic pregnancy
known or suspected pelvic infection
Have issues or concerns (in the judgement of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
Have previously participated in the study
Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.

Where it is running

Planned Parenthood Association of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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